Colorectal Cancer (MSI-H)Phase 2NIVO1002024NCT07523763
Neoadjuvant Low-dose Immunotherapy in Locally Advanced MMR-deficient Colorectal Cancer
A Phase 2 study testing Nivolumab and Pembrolizumab in people with Colorectal Cancer (MSI-H) and Colorectal Cancer (CRC), run by Blokhin's Russian Cancer Research Center at 1 site in Russia.
Trial summary
Patients with clinical stage II-III dMMR/MSI colorectal adenocarcinoma will be treated with low-dose immunotherapy: nivolumab 100 mg or pembrolizumab 100 mg. The duration of treatment is 6 months. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer (MSI-H), Colorectal Cancer (CRC)
- What is being tested?
- Nivolumab and Pembrolizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteRussia
- Study dates
- 22 Mar 2024to 31 Mar 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Availability of voluntarily signed informed consent from the patient
- Histologically confirmed adenocarcinoma of the colon or rectum;
- Locally advanced tumor - cT3-4N0-2M0 according to CT for tumors of the colon and sigmoid colon; cT3 with a depth of tissue invasion ≥5mm (cT2N0 and higher for lower ampullary cancer) or T4 or involvement of the lateral resection margins according to MRI for rectal cancer;
- Presence of MSI/dMMR in the tumor;
- ECOG 0-2;
- No contraindications to surgical treatment of malignancy
Who cannot join
- Previous therapy with the inclusion of monoclonal antibodies - anti-PD1, anti-PD-L1, anti PD-L2, anti-CTLA4 antibodies and other immunotherapy drugs
- The presence of any other malignant tumor, with the exception of radically treated basal cell carcinoma, cervical cancer in situ, currently or within 5 years before inclusion in the study
- Pregnant and lactating women, as well as planning pregnancy during the period of therapy in a clinical trial and 6 months after the end of therapy
- Patients with preserved reproductive potential who refuse to use adequate methods of contraception throughout the study and 6 months after the end of therapy or who agree to abstain from heterosexual contact.
- Previous systemic therapy with immunosuppressive drugs (including, but not limited to: prednisone, cyclophosphamide, azathioprine, methotrexate, thalidomide and TNF [tumor necrosis factor] antagonists) within 4 weeks before signing the informed consent form, or the need to use immunosuppressive therapy in during the first year of the study.
- The use of systemic glucocorticosteroids (GCS) in replacement doses (for example, in a dose equivalent to 10 mg of prednisolone per day or less), short-term use of systemic GCS (≤7 days), inhaled and topical GCS are allowed.
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- Active, known or suspected autoimmune diseases (patients with type 1 diabetes mellitus and hypothyroidism requiring only hormone replacement therapy, as well as autoimmune diseases with only skin manifestations [for example, vitiligo, alopecia or psoriasis without symptoms of psoriatic arthritis] are allowed to participate), that do not require systemic therapy);
- Patients with HIV infection, active hepatitis B, active hepatitis C.
- Life expectancy less than 6 months.
- The presence of a disease or condition that, in the opinion of the investigator, prevents the patient from participating in the study.
- Complicated course of the primary tumor, requiring urgent surgical intervention.
- Previously performed radiation or chemotherapy for colorectal cancer, with the exception of cases of metachronous tumors over 5 years ago;
- Persistence, progression or recurrence of the underlying disease or the presence of distant metastases
- Conditions limiting the patient's ability to comply with the requirements of the protocol (in the opinion of the investigator);
- Vaccination with live vaccines within 28 days before randomization;
- Participation in other interventional clinical trials less than 30 days before randomization (except in cases of dropout before the introduction of study therapy) and while participating in an ongoing clinical trial;
- Significant adverse events from previous therapy, with the exception of chronic and/or irreversible events that cannot influence the assessment of the safety of the study therapy (for example, alopecia);
- Hypersensitivity or allergic reactions to the administration of drugs manufactured using Chinese hamster ovary cells, severe allergic reactions, anaphylaxis or other hypersensitivity reactions to chimeric or humanized antibodies, or any of the components of the study drug.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase II Open-label Non-randomized Study of Neoadjuvant Low-dose Immunotherapy in Patients With Locally Advanced Colorectal Cancer With Microsatellite Instability (MSI)/Mismatch Repair Deficiency (dMMR)
Patients with clinical stage II-III dMMR/MSI colorectal adenocarcinoma will be treated with low-dose immunotherapy: nivolumab 100 mg or pembrolizumab 100 mg. The duration of treatment is 6 months.
Read the detailed description
Patients with clinical high risk stage II (T3 with extramural extension ≥ 5mm or T4), stage III dMMR/MSI CRC will be treated with low-dose immunotherapy: nivolumab 100 mg every 2 weeks or pembrolizumab 100 mg every 4 weeks, then will be underwent surgery after 6 months of immunotherapy. Pts who refuse surgery and/or in case of complete clinical response (cCR) will continue therapy up to 1 year.
- Conditions
- Colorectal Cancer (MSI-H), Colorectal Cancer (CRC)
- Being tested
- Nivolumab, Pembrolizumab
- Keywords
- colorectal cancer, MSI, dMMR, immune checkpoint inhibitors, low-dose immunotherapy
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NivolumabDrug
Nivolumab 100 mg infusion
PembrolizumabDrug
Pembrolizumab 100 mg infusion
| Study group | Role | What they receive |
|---|---|---|
| Nivolumab | Experimental | The patients will be treated with nivolumab 100 mg every 2 weeks during 6 months until surgery Receives: Drug: Nivolumab |
| Pembrolizumab | Experimental | The patients will be treated with pembrolizumab 100 mg every 4 weeks during 6 months until surgery Receives: Drug: Pembrolizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete response (pathological complete response - pCR + durable clinical complete response - cCR)
pCR: absence of malignant cells on the specimen of colon/rectal resection in patients who were previously treated with neoadjuvant immunotherapy cCR: absence of detectable tumor via endoscopy and MRI up to 6 months
Measured: up to 8 months
Secondary outcomes (6)
Durable complete clinical response rate (DRR)
A continuous response [complete or partial objective response] beginning within 6 months of treatment and lasting ≥6 months
Measured: up to 12 months
Progression-free survival (PFS)
Time from initiation of treatment to the occurrence of disease progression or death.
Measured: 12 months
Overall survival (OS)
Time from initiation of treatment to death.
Measured: 12 months
Objective response rate (ORR)
percentage of patients who achieve a response, which can either be complete response (complete disappearance of lesions) or partial response (reduction in the sum of maximal tumor diameters by at least 30% or more)
Measured: up to 8 months
Major pathologic response (MPR)
Rate of pathologic response TRG 1-2
Measured: up to 8 months
Incidence of Treatment-Related Adverse Events as assessed by investigator
Incidence of Adverse Events assessed according to CTCAE version 5
Measured: up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2026
- Study start22 Mar 2024
- Primary completion31 Dec 2025
- Study completion31 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal Cancer (MSI-H)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Blokhin's Russian Cancer Research Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07523763
- Sponsor's protocol ID
- 3
- Acronym
- NIVO1002024
- Status last verified
- Apr 2026
- First submitted
- 6 Apr 2026
- Last updated
- 17 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Open-label Non-randomized Study of Neoadjuvant Low-dose Immunotherapy in Patients With Locally Advanced Colorectal Cancer With Microsatellite Instability (MSI)/Mismatch Repair Deficiency (dMMR)
- ClinicalTrials.gov ID
- NCT07523763
- Acronym / sponsor ID
- NIVO1002024 / 3
- Conditions
- Colorectal Cancer (MSI-H), Colorectal Cancer (CRC)
- Keywords
- colorectal cancer, MSI, dMMR, immune checkpoint inhibitors, low-dose immunotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Blokhin's Russian Cancer Research CenterUniversity, hospital or other
- Study start
- 22 Mar 2024 (actual)
- Primary completion
- 31 Dec 2025 (actual)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 13 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Patients with clinical stage II-III dMMR/MSI colorectal adenocarcinoma will be treated with low-dose immunotherapy: nivolumab 100 mg or pembrolizumab 100 mg. The duration of treatment is 6 months.
Detailed description
Patients with clinical high risk stage II (T3 with extramural extension ≥ 5mm or T4), stage III dMMR/MSI CRC will be treated with low-dose immunotherapy: nivolumab 100 mg every 2 weeks or pembrolizumab 100 mg every 4 weeks, then will be underwent surgery after 6 months of immunotherapy. Pts who refuse surgery and/or in case of complete clinical response (cCR) will continue therapy up to 1 year.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nivolumab | Experimental | Drug: NivolumabThe patients will be treated with nivolumab 100 mg every 2 weeks during 6 months until surgery |
| Pembrolizumab | Experimental | Drug: PembrolizumabThe patients will be treated with pembrolizumab 100 mg every 4 weeks during 6 months until surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Availability of voluntarily signed informed consent from the patient
- Histologically confirmed adenocarcinoma of the colon or rectum;
- Locally advanced tumor - cT3-4N0-2M0 according to CT for tumors of the colon and sigmoid colon; cT3 with a depth of tissue invasion ≥5mm (cT2N0 and higher for lower ampullary cancer) or T4 or involvement of the lateral resection margins according to MRI for rectal cancer;
- Presence of MSI/dMMR in the tumor;
- ECOG 0-2;
Key exclusion criteria (18 listed)
- Previous therapy with the inclusion of monoclonal antibodies - anti-PD1, anti-PD-L1, anti PD-L2, anti-CTLA4 antibodies and other immunotherapy drugs
- The presence of any other malignant tumor, with the exception of radically treated basal cell carcinoma, cervical cancer in situ, currently or within 5 years before inclusion in the study
- Pregnant and lactating women, as well as planning pregnancy during the period of therapy in a clinical trial and 6 months after the end of therapy
- Patients with preserved reproductive potential who refuse to use adequate methods of contraception throughout the study and 6 months after the end of therapy or who agree to abstain from heterosexual contact.
- Previous systemic therapy with immunosuppressive drugs (including, but not limited to: prednisone, cyclophosphamide, azathioprine, methotrexate, thalidomide and TNF [tumor necrosis factor] antagonists) within 4 weeks before signing the informed consent form, or the need to use immunosuppressive therapy in during the first year of the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NivolumabNivolumab 100 mg infusion | Drug | Nivolumab |
| PembrolizumabPembrolizumab 100 mg infusion | Drug | Pembrolizumab |
Primary outcome
Complete response (pathological complete response - pCR + durable clinical complete response - cCR)
Time frame: up to 8 months
pCR: absence of malignant cells on the specimen of colon/rectal resection in patients who were previously treated with neoadjuvant immunotherapy cCR: absence of detectable tumor via endoscopy and MRI up to 6 months
6 secondary outcomes
Durable complete clinical response rate (DRR)
Time frame: up to 12 months
Progression-free survival (PFS)
Time frame: 12 months
Overall survival (OS)
Time frame: 12 months
Objective response rate (ORR)
Time frame: up to 8 months
Major pathologic response (MPR)
Time frame: up to 8 months
Incidence of Treatment-Related Adverse Events as assessed by investigator
Time frame: up to 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Nivolumab and Pembrolizumab in people with Colorectal Cancer (MSI-H) and Colorectal Cancer (CRC), run by Blokhin's Russian Cancer Research Center at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 17 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete response (pathological complete response - pCR + durable clinical complete response - cCR) (time frame: up to 8 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2026.